Status:
UNKNOWN
Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe Sepsis
Lead Sponsor:
Sirius Genomics Inc.
Conditions:
Severe Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Brief Summary
The overall purpose of the study is to determine whether either of the Improved Response Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients with severe sepsi...
Detailed Description
This will be a multicenter, "prospective-retrospective", controlled, matched-patients study. Retrospective phenotypic data and DNA samples will be obtained from patient registries and clinical trials ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for INDICATED population:
- Age ≥ 18 years
- Severe sepsis (must meet a, b, and c below)
- Suspected or proven infection
- Systemic Inflammatory Response Syndrome (SIRS)(must meet 2 of 4 criteria)
- Temperature \< 36°C or \> 38°C
- Heart rate \> 90 beats/minute
- Respiratory rate \> 20 breaths/minute or PaC02 \< 32 mm Hg) or on mechanical ventilation
- White blood cell count \< 4,000/mm3 or \> 12,000/mm3
- At least one organ dysfunction due to sepsis based on definitions of clinically significant organ dysfunction
- Cardiovascular dysfunction \[must meet one of (1), (2), or (3) below\]:
- Systolic blood pressure ≤ 90 mmHg and pH ≤ 7.3
- Mean arterial pressure ≤ 70 mmHg and pH ≤ 7.3
- Reported use of a vasopressor alone is sufficient evidence of shock
- Pulmonary dysfunction: PaO2/FiO2 ≤ 300 mmHg
- Central Nervous System dysfunction: Glasgow Coma Scale ≤ 12
- Coagulation dysfunction: platelets ≤ 80,000/mm3
- Renal dysfunction: creatinine ≥ 2.0 mg/dL
- Hepatic dysfunction: bilirubin ≥ 2.0 mg/dL
- High risk of death (one of a, b, or c below)
- APACHE II ≥ 25
- SAPS II ≥ 54
- Multiple organ dysfunction - two or more clinically significant organ dysfunctions (as defined above), which have occurred within 2 days of each other
- Platelet counts ≥ 30,000/mm3
- DrotAA status known
- Exclusion Criteria:
- Patients with no DNA
- Patients enrolled in local cohort more than 2 years before Xigris \[drotrecogin alfa activated)\] was commercially available
- A secondary analysis population with severe sepsis will be defined by Inclusion Criteria 1, 2, 4, and 5 above, and the Exclusion Criteria. This will be referred to as the SEVSEP population.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT01486524
Start Date
October 1 2011
End Date
April 1 2012
Last Update
December 6 2011
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
Johns Hopkins University, Bayview Medical Center
Baltimore, Maryland, United States, 21224
3
Harvard University School of Public Health
Boston, Massachusetts, United States, 02115
4
Vanderbilt University Schoo of Medicine
Nashville, Tennessee, United States, 73232-2650